What's the difference between Engineering (ECN) and Process (PCN) Change Notes?

R

ranvir.jaryal

#1
#1
I am a bit confused about these two,
ECN-Engineering Change note
PCN-Process Change Note,

How to differentiate these two.

Please guide.
 
Paper to QMS ad
Elsmar Forum Sponsor
J

Jgryn

#3
#3
In most organizations ECN's are items that affect the fit, form or function of the product. Something that the customer will notice and will affect how they use the product. This includes colour or material changes. Even if the material is replaced with a similar material, the validation testing will probably need to be repeated. Most ECN's require customer approval, or at least buy in.

PCN's are changes to how the product is made. A change in the order of how the product is assembled. Adjustment to the length of cooling time, etc. As long as the change does not affect the fit, form or function of the part, including material properties.

Jen
 
R

ranvir.jaryal

#4
#4
Hi stijloor and jen,

Thanks a lot for your valuable feedback.

This means changes affecting input material and product characteristics (fit, form and function including color) require-------ECN
Changes in between these two stages (like process parameters change, environment control change, process flow change) require ----PCN

Is my understanding correct?
 
kedarg6500

kedarg6500

Quite Involved in Discussions
#5
#5
Ranvir


Normally we do have ECN system which takes care of Engineering Changes, but we do not have system to track Process Changes. It is useful when doing CORRECTIVE ACTION investigation.:bonk:We have to keep Process Change log book OR Process Change Note. It is usually approved by Manufacturing Engineer. Without approval we should not implement Process Changes.

Kedar
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Difference between "Production Trial Run" and "Run at Rate" IATF 16949 - Automotive Quality Systems Standard 6
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R What's the major difference between Green Belt and Black Belt in term of training and project Six Sigma 3
T Difference between a subcontractor and a supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
H Difference between Stainless Steel 316 ASTM F899 and ASTM A276 Other Medical Device Related Standards 3
A Exact terms for a plating failure and difference between rejection rate and failure rate Manufacturing and Related Processes 9
M Difference between MSA and MSE? General Measurement Device and Calibration Topics 1
gramps What is the difference between discrete and continuous variables? Problem Solving, Root Cause Fault and Failure Analysis 5
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 2
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
Jimmy123 What is the difference between Error Proofing and Controls? ISO/IATF 16949 - Control Plans FMEA and Control Plans 16
C IEC 60601-1-8, difference between table 4 and annex D IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 6
Q What is the difference between AS9100D 9.3.2.f and 9.3.3.a AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Aluminum - What is the difference between 6061-T6 and 6061-T651 (both per ASTM B211)? Manufacturing and Related Processes 4
P What is the exact difference between Risk and Opportunity in context of ISO 27001? IEC 27001 - Information Security Management Systems (ISMS) 7
S Difference between Surface Finish (Ra) and Flatness (GD&T) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
O Air Flow - Which is the operational difference between LAF (vertical and horizontal) and RLAF? Manufacturing and Related Processes 2
S What the difference is between Stub Acme & Acme thread? Oil and Gas Industry Standards and Regulations 1
S DO 178B - What is the difference between review and verification? Federal Aviation Administration (FAA) Standards and Requirements 1
T The difference between SOP and Kaizen Standardization Lean in Manufacturing and Service Industries 2
K Difference between intended purpose and intended use of the device EU Medical Device Regulations 9
Q What is the difference between normal and licensed internal auditor? VDA Standards - Germany's Automotive Standards 9
J What is the difference between Process Variation and Tolerance? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
O Difference Between PFMEA & Control Plan FMEA and Control Plans 3
S Difference between an Advisory Notice (ISO 13485) and a Field Safety Notice? ISO 13485:2016 - Medical Device Quality Management Systems 3
T Difference between "data analysis" and "management review" ISO 13485:2016 - Medical Device Quality Management Systems 4
qualprod What is the difference between 7.4.1 (2008) and 8.4.1 (2015)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Difference between uncertainty and expanded uncertainty of measurement General Measurement Device and Calibration Topics 1
S EASA Part 145 - The difference between non-certifying staff and Certifying staff Federal Aviation Administration (FAA) Standards and Requirements 2
S The difference between a Medical Device Accessory and Component Canada Medical Device Regulations 2
S What is the difference between a service request and a complaint? ISO 13485:2016 - Medical Device Quality Management Systems 2
I What is the difference between OOS/OOT Imported Legacy Blogs 3
A Definition Difference between Quality System Procedure and Standard Operating Procedure (SOP) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
Q Difference between Monitor & Measurement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T QA vs. RA - The difference between QA and RA Coffee Break and Water Cooler Discussions 6
A Difference between Discrimination and Least Count IATF 16949 - Automotive Quality Systems Standard 2
K Difference between Medical Electrical Equipment and Medical Equipment System IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Usability Standard - The difference between IEC 60601-1-6 to IEC 62336 Human Factors and Ergonomics in Engineering 1
S What is the difference between Verification and Validation of Test Reports? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A Difference between ISO 9001:2015 Clauses 8.1 and 8.5.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M IATF 16949 Cl. 8.4.2.2 vs 8.6.5 - Is there any difference between these clauses? IATF 16949 - Automotive Quality Systems Standard 7
C What is the difference between "Overall Risk" and "Risk"? (ISO 14971) ISO 14971 - Medical Device Risk Management 10
C The difference between a Critical Dimension vs. Critical Characteristic Misc. Quality Assurance and Business Systems Related Topics 2
A ISO 9001:2015 - The difference between 6.1.1b and 6.1.1d - IMHO, d) implies b) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Difference between requirement for 4.4.1a (inputs) and 4.4.1d (resources needed)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R The difference between Feasibility Assessment and Contract Review Contract Review Process 2
V Difference between Non-Conformance, Variance and Deviation ISO 13485:2016 - Medical Device Quality Management Systems 7
A Difference between Environmental Impact and Risk ISO 14001:2015 Specific Discussions 7

Similar threads

Top Bottom